Dental caries, Pediatric Dentistry
Conditions
Interventions
Randomized controlled two-arm clinical trial with a parallel-group design, adopting a split-mouth model when two eligible permanent first molars are present per participant
target sample of 70 children/adolescents (6–16 years), 1:1 allocation with an expected 35 participants per protocol when considering the first eligible tooth per participant
when two teeth are eligible, each participant contributes one tooth to each arm
simple randomization generated electronically (randomizer.org) by a researcher not involved in treatment
single-blind masking with the outcome assessor blinded
Experimental arm: papain-based gel applied to the cavity for 40–60 seconds, removal of softened carious tissue with manual curettes, rinsing, gentle drying, and restoration with self-curing composite
Control arm: conventional caries removal with manual and/or rotary instruments without gel, followed by rinsing, gentle drying, and restoration with the same self-curing composite resin using the same
procedures are performed in a single visit per tooth immediately after allocation, and clinical time is measured from the start of cavity preparation to resin setting
Sponsors
Faculdade de Odontologia de Bauru da Universidade de São Paulo
Faculdade de Odontologia de Bauru da Universidade de São Paulo
Eligibility
Age
6 Years to 16 Years
Inclusion criteria
Inclusion criteria: Individuals aged 6 to 16 years; presence of at least one permanent first molar with occlusal caries lesion class I classified as International Caries Detection and Assessment System 4, 5 or 6
Exclusion criteria
Exclusion criteria: Individuals with systemic diseases or conditions that contraindicate the proposed procedures; caries lesions classified as International Caries Detection and Assessment System 1, 2 or 3; presence of severe hypoplasia, extensive fractures or pulp necrosis in permanent molars
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find shorter clinical time in restorative procedures of permanent first molars with occlusal caries lesions classified as International Caries Detection and Assessment System 4, 5 or 6 when using chemo-mechanical removal with papain-based gel compared to conventional removal with manual instruments, measured in minutes from the beginning of cavity preparation until the setting of the self-curing composite resin | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find restorations with better adhesion and higher clinical quality in the group treated with papain based gel compared to the conventional group evaluated at 6 12 and 24 months using the modified United States Public Health Service criteria considering retention marginal adaptation surface texture marginal discoloration and presence of secondary caries;It is expected to find greater child comfort during dental treatment in the group treated with papain based gel compared to the conventional group assessed immediately after the restorative procedure using the Visual Analog Scale for pain and discomfort ranging from 0 no pain or discomfort to 10 maximum pain or discomfort;It is expected to observe in both groups a positive impact of treatment on oral health related quality of life of children assessed using the Child Perceptions Questionnaire versions 8 to 10 and 11 to 14 Brazilian version administered before treatment initiation and every 6 months up to 24 months of follow up to monitor changes in perception over time | — |
Countries
Brazil
Contacts
Public ContactAna Todt
Faculdade de Odontologia de Bauru da Universidade de São Paulo
Outcome results
None listed